Skip to content
Product safetyFDAUnited StatesImports

Nonclinical Testing Terminology

22 September 2026

In plain English

FDA issues a direct final rule replacing references to animal or preclinical tests with nonclinical tests, adding definitions and conforming amendments in its safety and reporting regulations.

Read the official notice
Topic
Product safety
Regulator
FDA
Published
22 September 2026
For
Imports
Where it applies
United States
Source
FDA (Food and Drug Administration)

From the notice

The Food and Drug Administration (FDA, Agency, or we) is issuing a direct final rule that substitutes references to "animal" tests or studies with "nonclinical" tests or studies, adds a definition of the terms "nonclinical test" and "nonclinical study," and makes other comparable or conforming amendments in certain safety and reporting sections of its regulations. The direct final rule also substitutes "nonclinical" for "preclinical" and "in vitro" for consistency in terminology. The Agency i
The full text is at the source

Olive tells you which of these hit your products.

Olive reads every change like these against your own products, codes and trade lanes, whether you import, export or both, and drafts the update to your compliance program for your approval. Nothing changes without you.

Get startedLive demo

Olivra lists official notices for information only. It is not legal advice, and Olive is not a lawyer or a licensed customs broker. The official text at the source is what counts.

More from FDA

See everything Olive monitors